Health care workers are frequently exposed to a patient's blood or body fluids during the course of a medical procedure. In particular, health care workers are exposed to sharp medical instruments (sharps) that have had contact with a patient's blood or body fluid. If a medical instrument that has come in contact with a patient's blood or body fluids is not properly maintained and handled during and after a procedure, the health care worker may be infected through contact with the medical instrument.
Needle stick or puncture wound injuries are very common ways in which health care workers are infected with a patient's blood or fluid borne pathogens. In fact, accidental needle sticks and medical sharp caused injuries pose the most significant risk to health care workers for occupational transmission of various blood borne pathogens such as, for example, hepatitis B, hepatitis C, and human immunodeficiency virus (HIV).
In an effort to reduce the health care worker's high risk of exposure to infectious materials, the Occupational Safety and Health Administration (OSHA) of the U.S. Department of Labor has developed standards that are designed to minimize or eliminate the health care worker's exposure to blood or body fluid borne pathogens. Requirements for disposal of contaminated sharps include puncture resistant and liquid-proof containers, positive sealing ability both before and after use, specified colors, and a biohazard designation symbol. (Occupational Exposure to Blood-Borne Pathogens: Final Rule 29 C.F.R. 1910.1030.) Similar provisions are in force in other countries.
Part of this strategy is to reduce the health care worker's exposure to infectious materials and needle sticks by removing the hazards from the health care worker's environment without requiring extra actions on the part of the health care worker. Examples of such equipment include equipment designed to either eliminate the use of needles or provide passive protective mechanisms for needles or sharp devices.
Although there has been an emphasis on and general acceptance of the use of this type of protective equipment by health care workers having contact with infectious material, incorporation of needle-less or protected needle devices in clinical practice has been very limited because their usage is often quite cumbersome.
Several patents have issued that attempt to provide the health care worker with a safe apparatus for using needles, syringes, and other medical sharps. For example, U.S. Pat. No. 5,047,019 to Sirock and U.S. Pat. No. 5,092,462 to Sagstetter et al. teach devices for the safe removal and disposal of sharps from medical instruments. However, neither Sincock nor Sagstetter et al. teach a device that provides for safe needle or sharp disposal that does not require an additional effort on the part of the health care worker. U.S. Pat. No. 5,097,963 to Chernosky, et al. teaches a rack for temporarily storing surgical instruments during surgery. The rack has a series of individual grooves, each with an inclined bottom surface to incline the instrument toward its "user's" end. The sharp end of the instrument is disposed in the groove, and the grooves are separated by partition walls.
In addition, U.S. Pat. Nos. 5,099,992 to Heimreid and 5,024,666 to Pituch teach devices that allow the safe and user friendly removal and storage of needles and medical sharps. However, neither Heimreid or Pituch teach an apparatus that provides a one-unit device that sterilely houses needles and medical sharps prior to their usage and provides for their safe disposal after use.
Although others have taught pre-sterilized medical procedure kits (see U.S. Pat. Nos. 5,031,768 to Fisher; 4,522,302 to Paikoff), these kits do not allow the health care worker to readily remove and replace ready-for-use instruments, maintaining the instruments in an easily accessible position, and provide for the safe and easy disposal of the contaminated instrument.
With the above-described requirements for safe use and disposal in mind, it is therefore an object of the present invention to provide a device and medical procedure kit for the safe packaging, intermittent storage, and disposal of sharp medical instruments sterilely packaged self-contained medical procedure kit or tray. The device provides that an instrument may be readily removed, replaced and retrieved; and may also function as a puncture-resistant locking receptacle for discarding contaminated medical instruments.